Plantar Fasciitis of Both FeetNCT06139822
Hamstring Stretching in Plantar Fasciitis
A study testing Experimental Group in people with Plantar Fasciitis of Both Feet, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the effects of Hamstring stretching versus conventional treatment for plantar fasciitis. A randomized control trial was conducted at Cena Medical Center Rawalpindi and Midland Doctors Institute Muzaffarabaad. The sample size was 64 calculated through open-epi tool. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Plantar Fasciitis of Both Feet
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both Genders
- 25 to 45 years of age
- Participants having heel pain for more than one month.
- Participants having Windlass positive test.
- Participants having hamstring tightness.
- sit and reach test positive.
- Bilateral plantar fasciitis.
Who cannot join
- Patients with corticosteroid injection
- Fracture around ankle and Calcaneal
- Any soft tissue injuries around ankle.
- Other Neurological/ Musculoskeletal disorder
- Congenital foot anomalies
- Systemic medical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hamstring Stretching With Conventional Physical Therapy in Plantar Fasciitis
The purpose of the study is to compare the effects of Hamstring stretching versus conventional treatment for plantar fasciitis. A randomized control trial was conducted at Cena Medical Center Rawalpindi and Midland Doctors Institute Muzaffarabaad. The sample size was 64 calculated through open-epi tool. The participants were divided into two groups, interventional and control group each having 32 participants. The study duration was 1 year. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 25to 45 years participants with plantar fasciitis along with hamstring tightness were included in the study. Tools used in this study are Goniometer, Visual Analogue Scale(VAS) for pain, and Functional Foot Index (FFI) for pain and disability. Data was collected before treatment at baseline and after 1st and 2nd week of the application of interventions. Data analyzed through SPSS version 25.
Read the detailed description
Plantar fasciitis is one of the main causes of heel pain. it is caused by the micro trauma to the site of attachment of plantar fascia at its origin on the medial tubercle of calcaneus resulting in inflammation. Plantar fascia is a fibrous band present at the bottom of foot which attaches heel to each of the toes.plantar fascia has a windlass mechanism which continuously stretches and shortens facilitating foot movements during walk.
During the standing phase all the tension forces are gathered at calcaneal tuberosity, which is a site of attachment for plantar fascia on heel. Pain is generally present at the medial side of heel to the medial arch of the foot.
Plantar fasciitis is often caused in people who have long periods of standing, involved in activities like running, jumping or other repeated activities. After knowing the exact mechanism it is suggested that it should be termed as planter fasciosis.Plantar fasciitis accounts for almost 80% of the total heel pain experienced by the people.
Planter fasciitis is treated with various treatment options. Initially it is treated by conservative treatments such as, rest, ice massage, foot ware modification, oral analgesics, stretching techniques, physical therapy modalities, and night splinting. If pain do not resolve with conservative treatment then further treatment options will be extracorporeal shock wave therapy, cortisone injections and surgery.
Diana et al concluded that addition of manual techniques for trigger point release along with stretching of plantar fascia is more effective than stretching alone. In a randomized control trial with a follow up of 12 months high load strength training was found to be quicker and more efficient treatment for plantar fasciitis. another RCT conducted in 2017 reported that stretching of Achilles tendon along with plantar fascia is twice effective than only plantar fascia stretching.
Immobilization done by using splints at night is one of the best treatments to avoid contracture in plantar fascia during night. But they are also related to sleep disturbances and discomfort during night. By using night splint there has been a pain relief for shorter period of time. Night splints used alongside custom foot orthotics have better results than used alone. Controlled Ankle Movement is very effective in reducing pain in heel. It can be done by using walking boots and casts. These boots and casts will help to reduce over stretching of plantar fascia with unloading mechanism over heel. The reported reduction of pain by this mechanism of controlled ankle movement is in up to 40% of individuals.
Jonathan et al reported that there is a role of hamstring tightness in plantar fasciitis. A correlation study found a strong relationship between hamstring tightness and plantar fasciitis. patients having hamstring tightness are 8.7% more prone towards developing planter fasciitis.
Hamstring is found to be affected in patients with plantar fasciitis. Many studies found relationship of hamstring tightness with plantar fasciitis. Hamstring tightness affects the posterior muscles increasing load on plantar fascia. There is scarce evidence about the hamstring stretching in patients having plantar fasciitis. So this study will focus on hamstring stretching along with plantar fascia stretching and strengthening to improve pain, range of motion and disability.
- Conditions
- Plantar Fasciitis of Both Feet
- Being tested
- Experimental Group, Control Group
- Keywords
- Planter Faciatis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Also called Hamstring Streching
Hamstring stretching is the main intervention which is being used along with convention protocol for plantar fasciitis.
Control GroupOther
Also called cold pack, calf and plantar fascia stretchings and strenthening exercises
Control group included Cold pack for 7 to 10 mins. Followed by stretching of plantar fascia .
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | hamstring stretching, cold pack, stretching, strengthening of plantar fascia and calf muscles.
. Hamstring stretching will be used as an intervention protocol along with conventional physical therapy. Treatment protocol will be followed for thrice a week for 2 weeks. The session will be of approximately 20 minutes. Patient will be in supine lying, passively increase hip flexion while keeping the back straight, and the knee in the extended position from the start to the end of the stretching while the ankle will be in a neutral position
a 30-second rest period will be recommended between stretching repetitions. For each stretching repetition, the individual had to achieve a position of mild discomfort (not pain) which will sustain for 30 seconds. Receives: Other: Experimental Group |
| Control Group | Active comparator | Cold pack, stretching, strengthening of plantar fascia and calf muscles
Control group included Cold pack for 7 to 10 mins. Followed by stretching of plantar fascia through:
* toe stretches to stretch the plantar fascia.
* towel to stretch the bottom of foot (towel scrunches)
* calf muscles stretching
After stretching exercises strengthening is performed by the following:
* towel curls
* heel raise Patients performed 2 sets, each repetition lasting 30 seconds, 2 times a day for each exercise. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The visual analogue scale (VAS) is a scale that is used as a questionnaire. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end points.patient rates its pain between 0 to 10.
VAS Visual Analogue Scale changes measured at baseline after 1 week and sfter 2nd week.
Measured: upto 2 weeks
Secondary outcomes (2)
Goniometery for ROM(Range of Motion)
The art and science of measuring the joint ranges in each plane of the joint are called goniometry. Goiniometer is used to measure ankle range of motions specifically dorsiflexion and plantar flexion.
Changes from the Baseline ROM range of Motion of ankle in plantar flexion was taken with the Help of goniometer. Changes from the Baseline ROM range of Motion of ankle in plantar flexion was taken with the Help of goniometer and after 1st and 2nd week
Measured: upto 2 weeks
Functional Foot Index (FFI-R)
A Foot Function Index (FFI-R) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI-R is a self-administered index consisting of 68 items divided into 4 sub-scales. Both total and sub-scale scores are produced.
Functional Foot Index (FFI-R) is used to measure activity status and disability index at baseline and after every week.
Measured: upto 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Feb 2022
- Primary completion31 Dec 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Fasciitis of Both FeetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lal Gul Khan, MScPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139822
- Sponsor's protocol ID
- Riphah/RCRS/01223 Sunya Fiaz
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hamstring Stretching With Conventional Physical Therapy in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06139822
- Acronym / sponsor ID
- Riphah/RCRS/01223 Sunya Fiaz
- Conditions
- Plantar Fasciitis of Both Feet
- Keywords
- Planter Faciatis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the effects of Hamstring stretching versus conventional treatment for plantar fasciitis. A randomized control trial was conducted at Cena Medical Center Rawalpindi and Midland Doctors Institute Muzaffarabaad. The sample size was 64 calculated through open-epi tool. The participants were divided into two groups, interventional and control group each having 32 participants. The study duration was 1 year. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 25to 45 years participants with plantar fasciitis along with hamstring tightness were included in the study. Tools used in this study are Goniometer, Visual Analogue Scale(VAS) for pain, and Functional Foot Index (FFI) for pain and disability. Data was collected before treatment at baseline and after 1st and 2nd week of the application of interventions. Data analyzed through SPSS version 25.
Detailed description
Plantar fasciitis is one of the main causes of heel pain. it is caused by the micro trauma to the site of attachment of plantar fascia at its origin on the medial tubercle of calcaneus resulting in inflammation. Plantar fascia is a fibrous band present at the bottom of foot which attaches heel to each of the toes.plantar fascia has a windlass mechanism which continuously stretches and shortens facilitating foot movements during walk.
During the standing phase all the tension forces are gathered at calcaneal tuberosity, which is a site of attachment for plantar fascia on heel. Pain is generally present at the medial side of heel to the medial arch of the foot.
Plantar fasciitis is often caused in people who have long periods of standing, involved in activities like running, jumping or other repeated activities. After knowing the exact mechanism it is suggested that it should be termed as planter fasciosis.Plantar fasciitis accounts for almost 80% of the total heel pain experienced by the people.
Planter fasciitis is treated with various treatment options. Initially it is treated by conservative treatments such as, rest, ice massage, foot ware modification, oral analgesics, stretching techniques, physical therapy modalities, and night splinting. If pain do not resolve with conservative treatment then further treatment options will be extracorporeal shock wave therapy, cortisone injections and surgery.
Diana et al concluded that addition of manual techniques for trigger point release along with stretching of plantar fascia is more effective than stretching alone. In a randomized control trial with a follow up of 12 months high load strength training was found to be quicker and more efficient treatment for plantar fasciitis. another RCT conducted in 2017 reported that stretching of Achilles tendon along with plantar fascia is twice effective than only plantar fascia stretching.
Immobilization done by using splints at night is one of the best treatments to avoid contracture in plantar fascia during night. But they are also related to sleep disturbances and discomfort during night. By using night splint there has been a pain relief for shorter period of time. Night splints used alongside custom foot orthotics have better results than used alone. Controlled Ankle Movement is very effective in reducing pain in heel. It can be done by using walking boots and casts. These boots and casts will help to reduce over stretching of plantar fascia with unloading mechanism over heel. The reported reduction of pain by this mechanism of controlled ankle movement is in up to 40% of individuals.
Jonathan et al reported that there is a role of hamstring tightness in plantar fasciitis. A correlation study found a strong relationship between hamstring tightness and plantar fasciitis. patients having hamstring tightness are 8.7% more prone towards developing planter fasciitis.
Hamstring is found to be affected in patients with plantar fasciitis. Many studies found relationship of hamstring tightness with plantar fasciitis. Hamstring tightness affects the posterior muscles increasing load on plantar fascia. There is scarce evidence about the hamstring stretching in patients having plantar fasciitis. So this study will focus on hamstring stretching along with plantar fascia stretching and strengthening to improve pain, range of motion and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Experimental Grouphamstring stretching, cold pack, stretching, strengthening of plantar fascia and calf muscles. . Hamstring stretching will be used as an intervention protocol along with conventional physical therapy. Treatment protocol will be followed for thrice a week for 2 weeks. The session will be of approximately 20 minutes. Patient will be in supine lying, passively increase hip flexion while keeping the back straight, and the knee in the extended position from the start to the end of the stretching while the ankle will be in a neutral position a 30-second rest period will be recommended between stretching repetitions. For each stretching repetition, the individual had to achieve a position of mild discomfort (not pain) which will sustain for 30 seconds. |
| Control Group | Active comparator | Other: Control GroupCold pack, stretching, strengthening of plantar fascia and calf muscles Control group included Cold pack for 7 to 10 mins. Followed by stretching of plantar fascia through: * toe stretches to stretch the plantar fascia. * towel to stretch the bottom of foot (towel scrunches) * calf muscles stretching After stretching exercises strengthening is performed by the following: * towel curls * heel raise Patients performed 2 sets, each repetition lasting 30 seconds, 2 times a day for each exercise. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both Genders
- 25 to 45 years of age
- Participants having heel pain for more than one month.
- Participants having Windlass positive test.
- Participants having hamstring tightness.
Key exclusion criteria (6 listed)
- Patients with corticosteroid injection
- Fracture around ankle and Calcaneal
- Any soft tissue injuries around ankle.
- Other Neurological/ Musculoskeletal disorder
- Congenital foot anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupAlso: Hamstring StrechingHamstring stretching is the main intervention which is being used along with convention protocol for plantar fasciitis. | Other | Experimental Group |
| Control GroupAlso: cold pack, calf and plantar fascia stretchings and strenthening exercisesControl group included Cold pack for 7 to 10 mins. Followed by stretching of plantar fascia . | Other | Control Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: upto 2 weeks
The visual analogue scale (VAS) is a scale that is used as a questionnaire. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end points.patient rates its pain between 0 to 10. VAS Visual Analogue Scale changes measured at baseline after 1 week and sfter 2nd week.
2 secondary outcomes
Goniometery for ROM(Range of Motion)
Time frame: upto 2 weeks
Functional Foot Index (FFI-R)
Time frame: upto 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Plantar Fasciitis of Both Feet
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Not yet recruiting
Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis
Plantar Fasciitis, Heel Pain
Active, not recruitingObservational study
Evaluation of Spinal Posture, Balance, and Core Muscle Endurance in Individuals With Plantar Fasciitis
Plantar Fasciitis of Both Feet
Enrolling by invitation
Effects Of Instrument Assisted Soft Tissue Mobilization as Compared With Manual Longitudinal Friction Massage in Individuals With Plantar Fasciitis.
Plantar Fasciitis of Both Feet
Recruiting
Platelet Rich Plasma for Musculoskeletal Conditions
Osteoarthritis (OA), Osteoarthritis (OA) of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lal Gul Khan, MScPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Plantar Fasciitis of Both Feet, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: upto 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.